Genitourinary Tumors With Sacituzumab Tirumotecan
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
About this trial
RINGQUEST is a Phase 2, open-label, single arm, basket, investigator-initiated clinical trial of sacituzumab tirumotecan in patients with:
* Cohort 1: papillary renal carcinoma (pRCC). * Cohort 2: less frequent bladder tumors such as variant histology urothelial carcinoma (VH-UC). The most common VH-UC are nested, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant provides written informed consent for the study.
Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.
Cohort 1: papillary renal carcinoma (pRCC).
Cohort 1: Prior treatment with PD-1/PD-L1 and or tyrosine kinase inhibitors (TKIs)
Disqualifiers
Symptomatic brain metastases or leptomeningeal disease. Note: Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.
Has an active infection requiring systemic therapy other than those permitted in the inclusion criteria.
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
Trial design
Design model
Parallel
Treatments tested in this trial
Sacituzumab Tirumotecan (SKB264)
DrugSacituzumab tirumotecan will be administered by IV infusion on Days 1 of each 2-week cycle. There is a maximum duration of exposure for sacituzumab tirumotecan of 78 doses (approximately 3 years). Treatment may be prematurely terminated in case of disease progression, unacceptable toxicity, consent withdrawal, or physician criteria.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: papillary renal carcinoma (pRCC)Experimental treatment 1 intervention
Group B: Cohort 2: variant histology urothelial carcinoma (VH-UC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Assessed by the investigator through imaging follow-up (CT scan/MRI) using Response evaluation criteria in solid tumors (RECIST) version 1.1. This will be considered as the percentage of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period.
Time frame
Throughout the study period, up to 2 yearsSecondary outcomes
1
Duration of response (DoR)
Time from the first response (complete response \[CR\] or partial response \[PR\]) documentation to the date of the documented progressive disease (PD) as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. DoR will be summarized using Kaplan-Meier method.
Time frame
Throughout the study period, up to 2 years2
Progression-free survival (PFS)
Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment. PFS will be summarized using Kaplan-Meier method.
Time frame
Throughout the study period, up to 2 years3
Overall survival (OS)
defined as the time elapsed from the first dose of study treatment until death from any cause. Survival will be assessed by recording patient status at each visit. OS will be summarized using Kaplan-Meier method.
Time frame
Throughout the study period, up to 2 years4
Patient reported health-related quality of life (HRQoL)
assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), version 3. This is a standard guide with 30 recommendations designed to assess the health of cancer patients. Different scales are measured, including Global Health and Quality of Life, Functional Aspects, and Symptom Scales. The results for each dimension are linearly transformed to generate scores ranging from 0 to 100. Here we will report the total score: The top of the scale (100) represents "The best health you can imagine." The bottom of the scale (0) represents "The worst health you can imagine."
Time frame
Throughout the study period, up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
MFAR
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: